Antipsychotic Drug Risperdal Recalled Because of Odor

June 20, 2011 -- The musty odor that has led to recalls of various Johnson & Johnson products has now struck the company's Risperdal and generic risperidone antipsychotic medication.

The company is recalling some 16,000 bottles of brand-name Risperdal (3 milligram tablets) and some 24,000 bottles of its generic risperidone (2 milligram tablets). The generic version is marketed by Patriot Pharmaceuticals, a wholly owned subsidiary of J&J.

The products were sold between Aug. 27, 2010, and Feb. 15, 2011. The company believes that only 1,600 bottles of the recalled Risperdal and only 1,200 bottles of the recalled risperidone remain in the marketplace.

The recall follows two customer complaints of the products having an "uncharacteristic odor." As in previous recalls, the smell seems to be caused by TBA, a breakdown by-product of a chemical preservative used in wooden storage pallets. Even tiny traces of TBA give off a powerful odor.

TBA itself is not toxic, but the smell has made some people sick to their stomachs. No serious adverse events related to TBA have been reported for Risperdal or risperidone.

The recalled Risperdal and risperidone products are:

Package Description

NDC Code

Lot Number

Expiration

Risperdal (risperidone) Tablets 3 mg Bottles of 60 Tablets

50458-330-06

0GG904

May 2012

Risperidone Tablets 2 mg Bottles of 60 Tablets

50458-593-60

OlG175

August 2012

Patients taking Risperdal or risperidone should not stop taking their medication. Anyone noticing an unusual odor from the product should return the bottles to their pharmacist and contact their doctors if they have questions.